- As the Alzheimer's research community regains confidence in the beta-amyloid theory, Roche has re-committed to crenezumab and gantenerumab—both antibody drugs that target amyloid protein.
- Roche is moving crenezumab into phase III, while the company is also designing new clinical trials for gantenerumab.
- Interest in gantenerumab has been revived after researchers noted drug-related biological activity in cerebral spinal fluid (CSF) and brain scans.
For the last 20 years, there have been numerous Alzheimer's disease (AD) drugs that have failed at various stages of R&D—well over 100. However, during that time researchers have learned a lot that may make them reconsider some of those so-called failures. A couple of major things have happened. First, there has been a refocusing of who to treat and when, with more of a focus on patients with the earliest stages of AD, who have mild cognitive impairment (MCI). The thought process underscoring this approach is that it may be possible to start treatment early enough to stave off further neurologic degeneration and stop of the process of beta-amyloid plaque accumulation in the brain.
In addition, researchers are now able to use biomarkers as a proxy endpoint, which allows them to determine whether there is any potential early on in the clinical trial process. For Roche, crenezumab and gantenerumab had both suffered setbacks in clinical trials last year, and while both drugs could have ended up consigned to the dustbin of R&D history, that's not the case. In fact, the positive results from Eli Lilly's and Biogen's drugs have encouraged Roche to keep going. It's a classic example of a rising tide lifting all ships—and bodes well for researchers who want to keep working on specific AD drugs without giving up early in the process.
Only time, and more trials, however, will tell whether or not the industry's bet on the amyloid plaque theory will pay off.